Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
NCT07575269 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 571
Last updated 2026-08-06
Summary
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:
Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?
Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation.
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-07
- Primary Completion
- 2028-07-20
- Completion
- 2030-01-01
- FDA Device
- Yes
Countries
- United States
- Ireland
Study Locations
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